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This is an open-label, uncontrolled phase 4 study to assess the safety and immunogenicity of the Japanese encephalitis (JE) vaccine Ixiaro® (IC51) in an elderly population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IXIARO 0,5 ml | Other | IXIARO®, 0.5 ml (6 µg), intramuscular (i.m.) injection, two vaccinations, Days 0 and 28 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IXIARO® | Biological | IXIARO®, 0.5 ml (6 µg), intramuscular (i.m.) injection, two vaccinations, Days 0 and 28 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of subjects with serious adverse events (SAEs) and medically attended adverse events (AEs) during the vaccination period and until Day 70 after the first vaccination | until day 70 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of subjects with SAEs and medically attended AEs during the vaccination period and up to 6 months after the second vaccination | up to 6 months | |
| Rate of subjects with unsolicited AEs up to Day 70 after the first vaccination | up to Day 70 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut für Spezifische Prophylaxe und Tropenmedizin | Vienna | State of Vienna | 1090 | Austria | ||
| Medical University of Vienna - Klinische Pharmakologie |
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| ID | Term |
|---|---|
| D004672 | Encephalitis, Japanese |
| ID | Term |
|---|---|
| D004671 | Encephalitis, Arbovirus |
| D018792 | Encephalitis, Viral |
| D020805 | Central Nervous System Viral Diseases |
| D002494 | Central Nervous System Infections |
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| Rate of subjects with unsolicited AEs up to six months after the second vaccination | up to 6 months |
| Rate of subjects with abnormal safety laboratory parameters (hematology, clinical chemistry, urinalysis) up to Day 70 after the first vaccination | up to Day 70 |
| Rate of subjects with solicited local and solicited systemic AEs assessed with a subject diary for 7 consecutive days after each vaccination | 7 consecutive days after each vaccination |
| GMTs and SCRs for JEV neutralizing antibodies determined by PRNT at Day 70 | Day 70 |
| Vienna |
| State of Vienna |
| 1090 |
| Austria |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | Free and Hanseatic City of Hamburg | 20359 | Germany |
| Universitätsklinikum Rostock | Rostock | Rostock | 18057 | Germany |
| Berliner Centrum Reise- und Tropenmedizin | Berlin | State of Berlin | 10117 | Germany |
| D007239 | Infections |
| D000069544 | Infectious Encephalitis |
| D001102 | Arbovirus Infections |
| D000079426 | Vector Borne Diseases |
| D000096724 | Mosquito-Borne Diseases |
| D014777 | Virus Diseases |
| D012327 | RNA Virus Infections |
| D018177 | Flavivirus Infections |
| D018178 | Flaviviridae Infections |
| D004660 | Encephalitis |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000090862 | Neuroinflammatory Diseases |